Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites) (U24)

点击翻译按钮获取中文摘要

The Columbia University Medical Center-Weill Cornell Medical Center NNEXT site has increased the efficiency of clinical research sponsored by NINDS, by creating a shared infrastructure that has benefited from existing resources, including two CTSAs, to conduct seven Phase II exploratory trials and one biomarker study. Four studies are completed, and four are underway. The joint NNEXT site has been led by PIs Karen Marder M.D. MPH and Claudia Chiriboga M.D. MPH at CUMC, and now, emblematic of the increased synergy between CUMC and WCMC, Claire Henchcliffe M.D. DPhil at WCMC will join as PI. The two neuroscience centers have a long history of collaboration in research; their respective hospitals are combined (New York Presbyterian Hospital), and they both have CTSAs linked in a regional consortium, the NYCON. Since 2011 our institutions have strengthened their relationship through an emphasis on Precision Medicine’s “All of Us” program. Our aims are 1) To build upon the success of our joint neuroscience CUMC-WCMC clinical trials site, capable of conducting the planned five to ten NNEXT trials, by drawing on our extensive expertise in adult and pediatric neurology, neurosurgery, and basic neuroscience. We have developed a recruitment strategy for rare and more common neurological diseases, making use of our respective communities, ambulatory care networks, and advanced bioinformatics. Our recruitment efforts will dovetail with our three-pronged goal to educate families through bilingual (English and Spanish) disease-specific programs. We will be guided by a Recruitment Retention Core composed of individuals with expertise (minority recruitment, epidemiology) providing practical real-time problem-solving to NEXT trialists. 2) To leverage resources from the CTSA, Office of Clinical Trials, IRB, and the Office of Research Compliance and Training, at each center to efficiently identify and expeditiously recruit ethnically diverse participants who are followed to trial completion. 3) To participate in, and contribute to, the NNEXT network by developing our own clinical trials. We have identified a team of co-investigators at both sites who have experience in NIH, industry and foundation supported clinical trials, have demonstrated partnership with foundations, and have a commitment to mentorship. A NEXT Advisory Committee including senior leadership will provide guidance on both current and future projects. 4) To train the next generation of clinical and basic neuroscientists to become independent investigators, able to design and conduct clinical trials, and benefiting from new technologies and trial methodologies. To this end, we will organize a multifaceted program for faculty career-development. 5) To improve dissemination of information to patients, families, and disease-specific advocates about scientific advances and the importance of clinical trials in our community, using educationally and culturally appropriate tools, and innovations including telehealth to reach a broader public.